Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset

Acute Ischaemic Stroke Clinical Trial

— FUN-TPA  

Official title:

Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset: A Prospective Cohorts Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164357
• Other study ID #: FUN-TPA-2012-01
• Status: Completed
• Phase: N/A
• First received: June 12, 2014
• Last updated: December 17, 2015
• Start date: September 2012
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial Summary

This study will compare two ways of treatment for acute ischemic stroke: an endovascular treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed separately.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 80 or less years old patients with acute stroke produced by a main artery occlusion

• NIHSS National Institutes of Health Stroke Scale score greater than 6 (severe neurological impairment)

• Patients receiving EVT or IVT within 4.5 hours after onset

Exclusion Criteria:

• EVT or IVT contraindication

• Previous neurological impairment, severe concomitant disease or poor prognosis.

• Pregnancy or breastfeeding

• Known hypersensitivity to any study drugs

• Severe organic disease for which there is not risk compensation.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Ischaemic Stroke
• Ischemia
• Stroke

Intervention

Procedure:
• EVT (endovascular treatment )

• IVT (intravenous thrombolytic therapy)

Locations

Country	Name	City	State
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Universitario Doce de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death within 90 days after onset		90 days	Yes
Primary	Symptomatic intracranial haemorrhage		7 days	Yes
Secondary	Stroke recovery rate after discharge	Recovery defined as a 10-fold decrease in NIHSS or NIHSS (7 days after onset or at discharge)	From onset to discharge	No
Secondary	Functional recovery	Modified Rankin Score (RMS) value	4.5 hours after onset	No